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Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252794
Recruitment Status : Enrolling by invitation
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Gattu Tharun, Institute of Liver and Biliary Sciences, India

Brief Summary:
In this study, the investigators aim to prove that performing graft inflow modulation (GIM) in liver with portal hyper-perfusion is beneficial for early graft function postoperatively. Grafts at risk for portal hyper-perfusion will be identified by doing an intraoperative Doppler after reperfusion. In group A, the investigators will take 21 liver transplant recipients after reperfusion, randomly allocated, who will undergo intraoperative graft inflow modulation by splenic artery ligation. In group B, the investigators will be analyzing another randomly allocated 21 patients, who will not undergo any graft inflow modulation. The investigators will be analyzing trend of LFT's (liver function tests) after surgery, time for normalization of bilirubin, INR (international normalised ratio) and decrease in ascites, morbidity, mortality, ICU (intensive care unit) and total hospital stay.

Condition or disease Intervention/treatment Phase
Cirrhosis, Liver Procedure: Splenic artery ligation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Graft Inflow Modulation for Portal Hyper-perfusion in Live Donor Liver Transplantation: a Randomized Pilot Study
Actual Study Start Date : August 8, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients who undergo GIM
If inclusion criteria are met, after randomisation, these group of patients will undergo splenic artery ligation (graft inflow modulation)
Procedure: Splenic artery ligation
Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas

No Intervention: Patients who will not undergo GIM
If inclusion criteria are met, after randomisation, these group of patients will not undergo splenic artery ligation (graft inflow modulation)



Primary Outcome Measures :
  1. Incidence of early graft dysfunction [ Time Frame: first postoperative month ]
    Number of patients who develop early graft dysfunction in each group

  2. Time to normalisation of ascites output [ Time Frame: first postoperative month ]
    time to normalisation of ascites output (in days)

  3. Time to normalisation of INR [ Time Frame: first postoperative month ]
    time to normalisation of INR (in days)

  4. Time to normalisation of bilirubin [ Time Frame: first postoperative month ]
    time to normalisation of bilirubin (in days)


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: first postoperative month ]
    Morbidity as per Clavein Dindo classfification

  2. ICU stay [ Time Frame: first operative month ]
    Duration of ICU stay (in days)

  3. Mortality [ Time Frame: first postoperative month ]
    death

  4. Total hospital stay [ Time Frame: till 3 months after surgery ]
    duration of total stay in hospital after liver transplatation (in days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Portal Venous Pressure (PVP) > 15 mm Hg after reperfusion or
  • Portal venous flow (PVF) > 250 ml/min/100 gr of liver after reperfusion

Exclusion Criteria:

  • Significant peripancreatic collaterals preventing safe access to splenic artery
  • Acute Liver Failure as an indication for transplant
  • ABO incompatible transplants
  • Pediatric transplants
  • Refusal to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252794


Locations
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India
Institute of Liver and Biliary Sciences
New Delhi, India, 110074
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
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Principal Investigator: Gattu Tharun, MS Senior resident, Department of HPB surgery, ILBS, India
Additional Information:
Publications of Results:

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Responsible Party: Gattu Tharun, Senior Resident, HPB Surgery, Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT04252794    
Other Study ID Numbers: ILBS-Liver Transplant-02
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Liver Diseases
Digestive System Diseases